I'm having a tough time finding an appropriate analogy for Allergan's startling lawsuit against the FDA challenging the agency's restrictions on manufacturers' promotion of off-label uses for drugs. The Emperor's New Clothes doesn't quite get it; everyone's known of the FDA's barely presentable state of dress for quite a while. A trembling Oliver Twist asking, "Please sir, I want some more," is a little closer, but Oliver didn't have a passel of lawyers at his back. Maybe Ridley Scott's iconic 1984 Apple SuperBowl commercial smashing the oppressive image of Big Brother? A manical Jack Torrance smashing through the bathroom door in The Shining? Sorry, I always go one too far.
The general reaction among businesspeople I've spoken with is, congratulations, I hope they win. You might think that anyone in the media would fully support any effort to promote free speech, but the best I can muster at this point is congratulations, thanks for bringing the subject to the table, and I'll check back with you in a few years.
Essentially, Allergan is seeking the right to add "truthful, important information about common off-label uses of Botox" to product labels, though an Allergan win, of course, would have huge implications for all kinds of drugs and medical devices. Education about off-label uses of such products today is done in the realm of continuing medical education, peer- and non-peer-reviewed articles and word of mouth.
Commercial speech such as advertising has never enjoyed the same level of freedom as other kinds of speech and, frankly, all the past few years have shown is that a greater level of restriction is in the public interest. In the wake of headlines about Vioxx, record fines on Pfizer and Lilly, even Allergan itself being smacked with a black-box labeling on Botox earlier this year, the plaintiffs face a formidable task in showing that commercial speech is being unnecessarily restricted.
What clearly is in the public interest is some kind of independently regulated clearinghouse or other mechanism to enable timely review and dissemination of Phase 4 studies that support extended uses of products and devices beyond their initial approval. There is no argument that important and clearly beneficial data from these studies is not reaching patients, or even physicians for that matter. It's important to remember that neither the FDA nor the current system restricts education about off-label uses; it does restrict promotion of such uses. When the creative and dedicated people in this industry devise a way to ensure that promotion is based solely on science, we'll be better off. In that effort, I wish Allergan the best of luck.
